ACTG Leadership, Committees, and Centers

ACTG’s executive, scientific, and resource committees work to ensure the network’s scientific agenda remains at the forefront of our research and to prioritize new and emerging scientific insights.

Executive Committee & Network Leadership Steering Committee

ACTG Executive Committee (AEC) is the primary governing body of ACTG, with ultimate responsibility for all scientific, administrative, and fiscal decisions on behalf of the network. The AEC oversees the overall fiscal management of ACTG; develops network bylaws, policies, and procedures; establishes performance standards for network centers and sites; ensures timely analysis and dissemination of study results; and works to enhance representation of underserved populations in studies and as investigators in ACTG studies. The AEC is responsible for approving the leadership and membership of ACTG scientific and supporting committees. 

ACTG Network Leadership Steering Committee oversees the administrative, scientific, and laboratory management of ACTG and provides guidance to and coordinates the activities of the Leadership and Operations Center (LOC), the Network Coordinating Center (NCC), and the Statistical and Data Management Center (SDMC)

Scientific Agenda Steering Committee

The Scientific Agenda Steering Committee (SASC) oversees all aspects of the development, refinement, and conduct of the ACTG’s scientific agenda and research plan, ensuring a clinical research agenda that addresses the National Institute of Allergy and Infectious Diseases’ (NIAID) scientific priorities and that responds to changes in the field.

Behavioral Science Subcommittee of The SASC

The Behavioral Science Subcommittee works closely with all of the ACTG transformative science groups (TSGs) and collaborative science groups in protocol development. The subcommittee includes members with a wide array of behavioral science expertise working together to ensure that the most rigorous behavioral science methods are used to enhance the objectives of ACTG studies.

Data Management Committee

The Data Management Committee (DMC) works closely with the ACTG Data Management Center to develop and implement standardized electronic data collection methods and case report forms. The committee’s clinical, data management, and analysis expertise ensures collection of appropriate data from all sites to address the needs of ACTG clinical trials. The committee also coordinates ACTG’s data collection methods with other NIAID/Division of AIDS networks to ensure consistency.

Performance Evaluation Committee

The Performance Evaluation Committee (PEC) monitors the performance of all key ACTG elements to ensure efficient development, implementation, and completion of clinical trials and the publication of study results. The PEC continuously assesses the structural components of the ACTG including the LOC, NCC, SDMC, specialty and site laboratories, and clinical research sites (CRSs). The PEC’s membership encompasses the network’s CRSs, laboratories, SDMC, NCC, and community representatives.

Site Management & Clinical Care Committee

The Site Management & Clinical Care Committee (SMCCC) oversees logistical processes essential for successful implementation and completion of the ACTG scientific research agenda. The mission of the SMCCC is to provide practical advice and technical expertise in the areas of patient care, data collection and management, and site operations as they relate to the safe and successful execution of ACTG clinical trials. The SMCCC is composed of site coordinators, research nurses, regulatory and data management personnel, pharmacists, and representatives of allied organizations including the NIH Division of AIDS (DAIDS), the Frontier Science Technology and Research Foundation (FSTRF), and community representatives. The SMCCC has two subcommittees and six working groups:

• Protocol Development and Implementation Subcommittee (PDISC)
• Site Operations Subcommittee (SOS)
• Field Representatives Working Group
• Outreach, Recruitment and Retention Working Group
• Pharmacy Working Group
• Data and Quality Management Working Group
• Study Coordinators Working Group
• Training and Education Working Group

Underrepresented Populations Committee

The Underrepresented Populations Committee promotes and monitors the clinical trial participation of groups traditionally underrepresented in clinical research and recommends strategies through which the ACTG Executive Committee can enhance the participation of underrepresented populations and minority investigators in HIV/AIDS research. The definition of underrepresented populations includes but is not limited to racial and ethnic minorities, women, transgender individuals (and other sexual and gender minorities), individuals who use drugs, individuals who face barriers to adherence, and individuals with disabilities. Committee membership includes elected members and representatives from other committees and stakeholders within the ACTG. 

Women’s Health Collaborative Science Group

The Women’s Health Inter-Network Scientific Committee (WHISC) works to develop optimal strategies to treat HIV and related complications among women. The WHISC develops studies that address scientific questions of high importance to the health of women living with HIV and seeks to optimize recruitment, retention, and sex-specific analyses of women in clinical trials. It advises the ACTG on clinical trial language and makes recommendations regarding reproductive, contraception, and pregnancy issues. It serves as a liaison with other networks, groups, and agencies involved in the care and treatment of women to enhance communication and avoid duplication in clinical trials. The WHISC also seeks to mentor junior faculty with careers directed at research into the health of women living with HIV. The current WHISC scientific agenda seeks to assess optimal therapy for HIV/AIDS, TB, hepatitis, and “cure” strategies in women living with HIV over the course of their lifetime; identify critical drug-drug interactions between hormonal therapies and antiviral drugs, TB drugs, hepatitis treatment, and cure interventions in women living with HIV; and determine sex differences in comorbidities and responses to their treatments in people living with HIV.

Antiretroviral Therapy Strategies Transformative Science Group

The Antiretroviral Therapy Strategies TSG oversees ACTG studies evaluating the effectiveness of novel treatment strategies (including long-acting antiviral drugs and formulations, broadly neutralizing and other monoclonal antibodies, and novel combinations of biomedical and behavioral modalities) in sustaining virologic suppression and engagement in HIV care globally. The TSG also creates partnerships to evaluate promising treatment delivery technologies, interventions, and strategies; evaluates pharmacokinetic interactions between antiviral agents and other compounds; partners with other networks to strengthen/broaden the evaluation of novel treatment strategies with HIV prevention applications; and assists in the evaluation of novel therapeutic agents for emerging infectious diseases.

Comorbidities Transformative Science Group

The End-Organ Disease and Inflammation TSG (which includes virologists, immunologists, pharmacologists, and clinical and laboratory researchers) designs clinical trials of novel interventions that target end-organ diseases contributing to increased morbidity and mortality among people living with HIV. The TSG also conducts observational studies using existing ACTG data and samples to evaluate the causes and consequences of end-organ diseases and the role of HIV; interventional studies of other host-targeted therapies designed to enhance immune recovery; and studies to understand the influence of other key factors, such as age, race, and sex, on the clinical consequences of HIV.

Hepatitis Transformative Science Group

The ACTG Hepatitis TSG facilitates trials of novel therapeutics for liver disease related to hepatitis B, hepatitis C, and metabolic disorders, with a focus on people living with HIV. The Hepatitis TSG works to determine the best way to understand the efficacy and safety of promising therapeutic compounds and to consider unique populations; encourage and facilitate collaboration between relevant stakeholders in order to facilitate rapid protocol development and study enrollment; educate ACTG sites about candidate selection, drug-drug interactions, and novel strategies; encourage the participation of underrepresented individuals, including women and people of color; and encourage the training of the next generation of hepatitis researchers, with a particular focus on international investigators.

HIV Reservoirs And Viral Eradication (Cure) Transformative Science Group

The HIV Cure TSG aims to cure HIV either through the complete elimination of the HIV reservoir (“complete cure”) or by controlling the virus in the absence of antiretroviral treatment (“functional cure”). The Cure TSG aims to fully understand the HIV reservoirs in blood and tissues; identify and validate methods to quantify the HIV reservoir; understand the means by which people have been cured of HIV after bone marrow transplantation, and try to replicate them if possible; better understand the mechanisms that maintain the HIV reservoir and how they relate to immune activation and immune exhaustion; and identify the most promising new therapies to cure HIV and evaluate them in pilot studies.

Tuberculosis Transformative Science Group

The Tuberculosis (TB) TSG is responsible for the development, implementation, and oversight of the ACTG research agenda related to the treatment and prevention of TB with and without HIV co-infection. The TB TSG aims to develop shorter, safer treatment regimens for drug-susceptible and resistant TB; identify optimal TB preventive therapy for drug-susceptible latent TB infection and household contacts exposed to multi-drug resistant TB; identify regimens that treat TB meningitis and isoniazid-monoresistant TB; and optimize TB treatment and prevention for people with TB/HIV co-infection. The TSG also conducts transformative research to describe drug-drug interactions involving anti-TB therapy and ART, improve TB diagnostic assays and biomarkers to predict and detect disease and monitor response to therapy, and develop novel TB clinical trial designs.

Neurology Collaborative Science Group

The Neurology Collaborative Science Group (CSG) is made up of academic neurologists, psychiatrists, pharmacologists, virologists, and infectious diseases specialists. The committee includes working groups addressing HIV and aging, virology, mental health, women’s issues, and HIV cure. The areas of highest priority for investigation by the Neurology CSG include HIV-associated cognitive impairment; HIV eradication and the central nervous system as an HIV reservoir; mental health and behavior of people with HIV; HIV-associated CNS opportunistic infections; neurologic toxicities of ARVs and other drugs; and distal sensory peripheral neuropathy.

Global Community Advisory Board

The ACTG Global Community Advisory Board (GCAB) supports community outreach, education, and participation in research, and represents community concerns in the ACTG. The GCAB provides an opportunity for affected communities and especially participants in ACTG clinical trials to better understand the clinical research process and voice questions or concerns regarding clinical studies and their development, implementation, and outcomes. GCAB members contribute their knowledge, perspective, and lived experiences to efforts to enroll and retain trial participants and advocate on behalf of clinical trial participants. They ensure that trial materials are available in all appropriate languages and promote ethical research practices. Members also have the opportunity to volunteer for protocol teams and subcommittees and mentor new members and ask for mentorship when needed. 

Community Scientific Subcommittee of The GCAB

Participation by the community on ACTG committees and protocol reviews is conducted through the Community Scientific Subcommittee (CSS) of the GCAB.

Leadership And Operations Center

The ACTG Leadership and Operations Center (LOC) Administrative Core includes teams focused on Grants & Contracts, Budget & Finance, and Leadership Support and is housed within the Division of Infectious Diseases at the University of California Los Angeles (UCLA). The LOC is responsible for managing all funds awarded to the LOC and Laboratory Center (LC); developing/negotiating and managing budgets, contracts, and spending; maintaining all LOC and LC administrative and fiduciary records; supporting annual ACTG network meetings and leadership and scientific retreats; maintaining the financial conflict of interest disclosure program; tracking ACTG publications and ensuring compliance with NIH open-access requirements; preparing annual progress reports and other administrative reports to the DAIDS; providing administrative and financial support to the AEC; and coordinating ACTG external communications.

Statistical and Data Analysis Center 

Senior-level biostatisticians at the Statistical and Data Analysis Center (SDAC) provide complete statistical support, from study design through data analysis and publication for phase 1 through phase 4 clinical trials, diagnostic studies, and observational studies. These biostatisticians are among the leading experts in clinical trial design and analysis and are associated with the Harvard T.H. Chan School of Public Health. SDAC biostatisticians are core members of each protocol team, providing statistical expertise from study inception through publication and they take a leadership role in designing, conducting, and reporting results from clinical trials and observational studies. In addition, they prepare and present interim analyses of data from clinical trials to independent Study Monitoring Committees and Data and Safety Monitoring Boards; lead self-initiated research, including within-study and cross-study data analysis to address important clinical research questions, and clinical trial and observational study methods research; and mentor and train the next generation of statistician-trialists and investigators from international collaborating research sites interested in the application of quantitative sciences to HIV and other infectious disease research.

Data Management Center 

The ACTG Data Management Center (DMC) at Frontier Science Foundation acts as a liaison between the team and the clinical sites for all aspects of study-required data. The DMC facilitates the design and development of electronic case report forms to optimize study data collection; participates in protocol- and site-specific training; monitors the timeliness and quality of study data and works with sites to address issues or delinquencies; provides advice and instruction about the accurate completion of study forms to sites; and prepares data for annual FDA progress reports and others as needed.

Repository Advisory Group

The Repository Advisory Group (RAG) is a collaboration between the ACTG and IMPAACT clinical trials networks to make a large body of specimens collected from network studies available to investigators. These stored specimens were initially collected for studies that have since been completed and they are now available to investigators to conduct new research. The RAG sets all policies and procedures for specimen collection, processing, and shipment for both networks, and monitoring key performance indicators related to sample shipment. The RAG is chaired by the Lab Center PI, the Repository Manager of the Central Specimen Repository (Biomedical Research Institute), and representatives from the ACTG and IMPAACT Lab Centers, the Data Management Center, and DAIDS. 

Network Coordinating Center

The ACTG Network Coordinating Center (NCC), housed at Social & Scientific Systems, Inc. (SSS, DLH Holdings Corp Company), collaborates with ACTG leadership to provide technical, scientific, administrative, and project management support and expertise for the network. The NCC coordinates and facilitates implementation of the ACTG scientific research agenda and ensures compliance with network policies and procedures among ACTG leadership, sites, and partners. Among its responsibilities, the NCC provides support for:

• Leadership, scientific, and resource committees; protocol teams; clinical research sites; and community advisors
• Protocol development and implementation and publication of ACTG research
• Site development, assessment, training, and quality assurance
• Network communications, including quality assurance for information stored on the network’s Management Information System (MIS) and secure web-based document management system, integration with Network websites, and coordination with other DAIDS-funded networks

As an ACTG Network Consortium Partner, the NCC Director is a member of the AEC.